iCo Therapeutics Inc. Recognized by BIOTECanada with Gold Leaf Award
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iCo Therapeutics announced that its Phase 1 clinical trial of iCo-007, having enrolled all patients in four cohorts of increasing concentration (110ug, 350ug, 700ug, 1000ug), has to date demonstrated a positive safety profile. A Safety Evaluation Committee recently convened to review early data from the fourth and final cohort, which represented an approximately 10-fold increase in concentration from the first dosing level and concluded there were no drug-related serious adverse events. Based on the safety profile and additional encouraging data seen so far, iCo has now entered the planning stage for Phase 2 clinical studies.
Stated Dr. David Boyer: “I am pleased with the results of the Phase I clinical trial to date. The Safety Evaluating Committee’s experience with iCo-007 indicates that the drug has been well tolerated by patients and there were no drug-related significant adverse events noted to date even at the highest dosing level. I look forward to working with iCo in the planning and design of Phase 2 trials for iCo-007”. In early Q1 2010 iCo expects a last patient visit (month six) followed by data lock and analysis. iCo expects to present final data in Q2 2010.
The primary objective of the phase I, open-label, dose escalation study was to evaluate the safety and tolerability of a single intravitreal injection of iCo-007 in patients with diffuse DME. Secondary objectives included assessment of systemic pharmacokinetics, changes in retinal thickness using OCT measurements, and changes in visual acuity.
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